Us vs Fluoroscopic Guided Renal Access

NCT ID: NCT04090255

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2021-04-01

Brief Summary

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this present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrostomy pcn .

Detailed Description

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investigators will enroll 100 patients who are candidates for PCN in the study. By simple random sampling technique, patients will be assigned to two patient groups (group 1, US-guided approach , group 2, fluoroscopy-guided approach.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.

Conditions

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Hydronephrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Ultrasonographic guided renal access

The use of ultrasound to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine

Group Type EXPERIMENTAL

Renal puncture

Intervention Type PROCEDURE

The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn

Fluoroscopic guided renal access

The use of fluoroscopy to make a puncture in kidney for pcn for drainage or evaluation of function or for shunt of urine

Group Type EXPERIMENTAL

Renal puncture

Intervention Type PROCEDURE

The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn

Interventions

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Renal puncture

The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* infected hydronephrotic kidney onen's grade 2-3
* obstructed good cortex with backpressure changes onen's grade 2-3 .
* Evaluation of function of asymptomatic hydronephrotic kidney thin cortex onen's grade 4

Exclusion Criteria

* congenital anomalies of kidney
* patient underwent transplant or urinary diversion
* solitary kidney
Minimum Eligible Age

6 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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mostafa kamel abdel rahman abdel aal

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fathy G Elanany, Prof

Role: STUDY_DIRECTOR

Assiut

Mohamed A Sayed, Prof

Role: STUDY_DIRECTOR

Assiut

Hosney M Bahnasawy, Ass Prof

Role: STUDY_DIRECTOR

Assiut

Locations

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Mostafs Kamel Abdel Rahman

Asyut, Sedfa, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mostafa K Abdel rahman, A lecturer

Role: CONTACT

+201061133200

Facility Contacts

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mostafa k abdel rahman, resident

Role: primary

+201061133200

References

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Chen X, Peng PX, He YH, Ding ZS, Wang JF, Tan YW, Zhou XF. [Evaluation and Comparison of SHA.LIN,S.T.O.N.E.Nephrolithometry Scoring System,and Clinical Research Office of the Endourological Society Nephrolithometry Nomogram for Predicting Stone Free Rate and Postoperative Outcomes after Percutaneous Nephrolithotomy]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2019 Aug 30;41(4):492-500. doi: 10.3881/j.issn.1000-503X.10767. Chinese.

Reference Type BACKGROUND
PMID: 31484611 (View on PubMed)

Zanetti SP, Boeri L, Gallioli A, Talso M, Montanari E. Minimally invasive PCNL-MIP. Arch Esp Urol. 2017 Jan;70(1):226-234.

Reference Type BACKGROUND
PMID: 28221157 (View on PubMed)

Gulati M, Cheng J, Loo JT, Skalski M, Malhi H, Duddalwar V. Pictorial review: Renal ultrasound. Clin Imaging. 2018 Sep-Oct;51:133-154. doi: 10.1016/j.clinimag.2018.02.012. Epub 2018 Feb 16.

Reference Type BACKGROUND
PMID: 29477809 (View on PubMed)

Qiu Z, Yang Y, Zhang Y, Sun YC. Modified biological training model for percutaneous renal surgery with ultrasound and fluroscopy guidance. Chin Med J (Engl). 2011 May;124(9):1286-9.

Reference Type BACKGROUND
PMID: 21740734 (View on PubMed)

Other Identifiers

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Renal puncture

Identifier Type: -

Identifier Source: org_study_id

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